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TreatmentUpdate 173Volume 21 Issue 4 2009 May/June I ANTI-HIV AGENTS: C. Raltegravir—results after two yearsThe initial clinical trials of raltegravir were of a relatively short duration. Since raltegravir represents an entirely new class of anti-HIV drugs, it is important that people who use it are monitored for possible side effects. So regulatory authorities in the European Union and United States have asked the developer of raltegravir, Merck, to continue to monitor the health of people who use the drug for five years. In this report we combine the latest results from participants in two clinical trials of raltegravir—Benchmrk 1 and Benchmrk 2. Study detailsRaltegravir was used by people who had HIV that was resistant to drugs from commonly used classes of anti-HIV medicines. All participants were given what the researchers called optimal background therapy (OBT)—an individualized combination of anti-HIV drugs that researchers prescribed by taking into account each participant’s treatment history and resistance profile. Clinical trial volunteers were randomly assigned in a 2 to 1 ratio to one of the following study groups:
The average profile of participants at the time they entered the study was as follows:
Results—after 96 weeksOverall, the proportion of clinical trial participants in each group whose viral load was less than 50 copies was as follows:
This difference was statistically significant; that is, not likely due to chance alone. A closer look at combinationsIn this clinical trial of treatment-experienced patients, those who had not previously used powerful new anti-HIV drugs—such as T-20 (Fuzeon) or darunavir (Prezista)—and who received them as part of their OBT regimen were able to suppress their viral load below 50 copies as follows:
With darunavir as the only powerful new drug in the OBT, the results were as follows:
And if there were no powerful new drugs in the OBT, the virologic results were like this:
These results demonstrate that raltegravir has powerful anti-HIV activity and when it’s used with other active drugs, the results are even better. Bear in mind that the participants in this trial were treatment-experienced and had few treatment options. Because of their relatively low CD4+ counts (an average of 120 cells at the start of the study), they were at risk for a range of health complications. Not surprisingly, some deaths from AIDS-related complications occurred. However, people who received raltegravir were less likely to have the following events happen:
On average, the CD4+ cell count of raltegravir recipients increased by 123 after 96 weeks in the study, compared to an increase of 49 for participants who received placebo. This difference was statistically significant. Side effects—overallAs participants were generally in poor health when they entered the study, they may have been more susceptible to drug side effects. Perhaps because their health did not significantly improve, serious side effects were more common among people who received placebo. Side effects—symptomsThe following side effects were more common among people who received placebo:
However, fatigue was more common among raltegravir users. Side effects—lab testsIn this study, seriously abnormal laboratory test results were uncommon. Based on the data supplied by Merck, it is difficult to assess which abnormal laboratory results were due to exposure to raltegravir. For instance, higher-than-normal levels of cholesterol were seen in some raltegravir users (10%) compared to people on placebo (6%). However, raltegravir has not caused this problem in other clinical trials and changes in cholesterol may have been due to the complex regimens in the OBT, many of which probably contained ritonavir (Norvir). Moreover, the difference was not statistically significant. SummaryRaltegravir, as part of combination therapy, proved to be of potent and durable benefit in this study. In participants who received an OBT regimen of active anti-HIV drugs, up to 79% of those taking raltegravir had viral loads below the 50-copy mark after two years of use. Raltegravir was generally well tolerated. REFERENCE:
Created on: 2009 June 9 Author: Hosein SR |
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Decisions about particular medical treatments should always be made in consultation with a qualified medical practitioner who is knowledgeable about HIV-related illness and the treatments in question. MORE | |